Fresenius Kabi recalls Ivenix Infusion System over leaks that delay, interrupt therapy
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Key takeaways:
- The FDA has announced a class 1 recall, indicating that continued use may cause serious injuries or death.
- Health care facilities are urged to stop using the infusion system and contact the company.
The Ivenix Infusion System has been recalled by its manufacturer due to a system leak that may compromise the ability of the equipment to properly deliver infusions, according to press release from the FDA.
The FDA classified the recall by Fresenius Kabi USA as a class 1 recall, indicating that continued use of the recalled devices “may cause serious injuries or death.”
The Ivenix Infusion System model LVP-0004, a large volume pump used in health care settings to administer fluids to patients in controlled infusion amounts, was distributed from Oct. 27, 2021, through Jan. 30, 2023, according to the release. The notice implicates 1,546 devices in the United States.
“Fresenius Kabi USA, LLC is recalling the Ivenix Infusion System due to a leak in the system that allows fluid to enter the administration set loading area near the air detector,” the release said. “The leak damages the electrical system, leading to loss of power and failure of the system’s set identification (Set ID) sensor. Depending on the timing of the failure, this can delay or interrupt treatments.”
According to the FDA, this issue may lead to serious injury or death for patients due to interruption, under-infusion or delays in the infusion process.
The company has received 14 complaints related to the issue, but there have been no cases of patient injury or death related to the machine, the FDA said.
Health care practitioners who are using the system are advised to follow these steps:
- Make certain there are backup large volume pumps in situations where interruptions or delays can be dangerous.
- Use a different pump if there are serious delays or issues with the recalled device.
- Pay close attention to the function of alerts on the device.
- Make efforts to reduce and avoid if possible fluid buildup on the air detector component.
- Visually inspect the air detector component if the device displays “reload cassette” or “tubing set removed” warnings.
- Report continued “reload cassette” warnings.
- Stop using the infusion system.
- Post warnings regarding the system at all nursing stations.
Fresenius Kabi USA initially sent an Urgent Medical Device Recall letter to customers regarding the issue on March 10. The company acquired Ivenix and its infusion pump in May 2022.
Practitioners with additional questions should contact the company via email at ivenix_support@fresenius-kabi.com or by calling 1-978-775-8100.
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